Your search for "clinical study reports" matched 56 page(s).
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Health economic evaluations are relevant to those making healthcare resource allocation decisions, such as listing a new drug on the national formulary or launching a new vaccination programme. Compared with clinical studies that report only the…
Lay summaries are critical for building publictrust in clinical research and therefore forrecruiting patients. They are also an importantpart of efforts to improve data transparency.Due to new global regulations, lay summarieswill soon probably…
The first part of this article compares the main features of studies based on patient registry data with those of randomised clinical trials, providing a basis for better understanding the differences between the two. The second part details how to…
The discussion section of a clinical study report The discussion section of a clinical study report (CSR) is often a source of doubt among medical writers. The advice is usually to keep the discussion section as short as possible and not go…
Lay summaries of Phase I trials in healthy volunteers pose a challenge because their endpoints are complex, the targeted indication may not be known when they are conducted, their results are often reported years after the trial ended, and the…
Prior to this project, no patient lay summary (PLS) had ever been developed locally in Japan. In order to create a PLS that is more tailored to local patients, we attempted to develop one in and for Japanese. Such PLS was drafted based on the…
When medical writers discuss authors and authorship – the theme of this issue of medical writing – they are usually referring to documents in the public domain such as journal articles or maybe congress abstracts. The primary purpose of such…
Analyses of integrated databases of efficacy and safety are a Food and Drug Administration (FDA) requirement. They are very useful in evaluating the safety and efficacy data gathered in multiple clinical studies. However, their utility is dependent…
Something less beguiling for a horror-story addict than the emergence of obesity would be hard to imagine. Start by reading the 27 August 2011 issue of the Lancet. One article predicts that the obesity rate in the UK will make the tremendous leap fro…
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